LIMITATIONS OF THE TEST
1. This reagent is a qualitative test and cannot be used for
quantitative determination of antibody content.
2. This reagent is used for the detection of human whole blood,
serum or plasma samples. It cannot be used for the detection of
saliva, urine or other body fluids.
3. The test results of this product are for clinical reference only
and should not be used as the sole basis for clinical diagnosis and
treatment. The clinical management of patients should be considered
in combination with their symptoms / signs, medical history, other
laboratory tests, treatment response, and epidemiology.
4. In the early stage of infection, if the virus-specific IgM
antibody is not produced or the titer is very low, it will lead to
negative results. If a virus infection is suspected, the patient
should be reminded to check again within 10-20 days and take a
second sample, which should be the same as the first sample.
Simultaneously test under conditions to determine if there is a
seroconversion or a virus-specific IgG or IgM antibody titer that
is significantly
higher in the first infection.
5. The interpretation of positive results should be further
determined in conjunction with clinical symptoms and other
etiological methods (nucleic acid and sequencing).
6. Negative results indicate that no new coronavirus IgM / IgG
antibodies have been detected, but if the new coronavirus IgM / IgG
antibody content in the sample is below the minimum detection limit
of the kit, negative results may also be obtained.
TEST PROCEDURE
1. Please read the manual of the kit before operation.
2. If the sample is stored refrigerated or frozen, please allow the
sample to fully melt at room temperature (20-30 ° C), and mix the
sample upside down before use.
3. Before starting the test, remove the test strip from the
aluminum foil bag, lay it flat on the table, and mark the sample
number.
4. Use a sample gun or a dropper to draw 10ul of the sample to be
tested (serum, plasma or whole blood sample) into the sample well
on the test card. Immediately add 2 drops (70-90ul) of the sample
dilution solution to the sample well, and avoid significant bubbles
during operation.
5. Count and read the results within 15 minutes at room
temperature.
Please strictly control the reaction time and read the result
within 15 minutes.
Interpretation of test results
The test results are divided into three cases: negative, positive
or invalid. The specific interpretation methods are as follows:
| M line | G line | C line | Result |
| No color | No color | Color rendering | Negative, no new coronavirus antibodies detected |
| Color rendering | No color | Color rendering | Positive, new coronavirus IgM antibody detected, no new coronavirus
IgG antibody detected |
| No color | Color rendering | Color rendering | Positive, new coronavirus IgG antibody detected, new coronavirus
IgM antibody not detected |
| Color rendering | Color rendering | Color rendering | Positive, Simultaneous detection of novel coronavirus IgM and IgG
antibodies |
| Color rendering | No color | No color | Invalid test, need to re-measure |
| No color | Color rendering | No color | Invalid test, need to re-measure |
| Color rendering | Color rendering | No color | Invalid test, need to re-measure |
